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Problem-Solving Therapy for People With Major Depression and Chronic Obstructive Pulmonary Disease

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem Solving-Rx Adherence (PSA)
PID-C
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, Geriatric Depression, Problem-Solving Therapy, Treatment Adherence

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meets American Thoracic Society criteria for COPD
  • Meets DSM-IV criteria for unipolar major depression
  • Scores greater than 19 on 24-item Hamilton Depression Rating Scale
  • Fluency in English sufficient for comprehending the questionnaires of the study and for understanding the therapists

Exclusion Criteria:

  • Unable to give informed consent
  • Experiencing suicidal thoughts
  • History of or currently meets DSM-IV criteria for the following Axis I disorders: psychotic depression, psychotic disorder, bipolar disorder, dysthymic disorder, obsessive compulsive disorder, or current substance abuse
  • Meets DSM-IV criteria for Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV)
  • Scores less than 24 on Mini-Mental State Exam (MMSE) or meets DSM-IV criteria for dementia
  • Certain illnesses (e.g., untreated thyroid or adrenal disease, pancreatic cancer, lymphoma)
  • Taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids)
  • Current involvement in psychotherapy
  • Requires nursing home placement after discharge

Sites / Locations

  • The Burke Rehabilitation Hospital
  • Weill Medical College of Cornell University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Problem Solving-Rx Adherence (PSA)

PID-C

Arm Description

Participants will receive problem-solving therapy integrated with adherence-enhanced procedures (PSA).

Participants will receive adherence-enhanced (PID-C) procedures, a treatment mobilizing patients to participate in their care.

Outcomes

Primary Outcome Measures

Depressive symptoms

Secondary Outcome Measures

Full Information

First Posted
January 14, 2008
Last Updated
July 13, 2016
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00601055
Brief Title
Problem-Solving Therapy for People With Major Depression and Chronic Obstructive Pulmonary Disease
Official Title
Treating Older Patients With Major Depression and Severe COPD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the effectiveness of problem-solving therapy combined with treatment adherence procedures in treating older people with major depression and chronic obstructive pulmonary disease.
Detailed Description
Depression is a serious illness that affects a person's mood, thoughts, and physical well-being. Common symptoms of depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. Depression often occurs in the presence of one or more other disorders. For example, depression is reported to be at a higher rate in people with chronic obstructive pulmonary disease (COPD) than in the general population. COPD is a disease in which the lungs are damaged, making it difficult to breathe. Symptoms most commonly include chronic coughing and shortness of breath. A primary cause of COPD is cigarette smoking. Following a prescribed treatment plan is important for managing COPD. Unfortunately, people with COPD often do not adhere to their treatment plans. Being depressed makes adherence even more difficult. This study will evaluate the effectiveness of problem-solving therapy integrated with adherence-enhanced procedures (PSA) in treating older people with major depression and COPD. Participants in this open label study will be randomly assigned to one of two groups: PSA or PID-C. In PSA, a therapist will teach participants problem-solving strategies focusing on treatment adherence, depressive symptoms, and disability. Participants will learn behaviors and solutions to help cope with these problems. In PID-C, a therapist will teach participants to identify obstacles to treatment adherence and to discover ways to overcome them. The treatment sessions for both groups will be initiated at the inpatient Pulmonary Unit of Burke Rehabilitation Hospital and will continue in the participants' homes. All participants will receive two treatment sessions during hospitalization, eight weekly sessions following discharge, and four monthly sessions after that. While hospitalized at Burke, participants will also undergo an assessment interview for 1.5 hours and another interview for 20 minutes 2 weeks following the initial assessment. Interviews lasting 1.5 hours will also occur in the homes of the participants at Weeks 10, 14, and 26 after discharge from Burke. All assessments will focus on depression severity, level of general functioning, and COPD treatment adherence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Depression
Keywords
COPD, Geriatric Depression, Problem-Solving Therapy, Treatment Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem Solving-Rx Adherence (PSA)
Arm Type
Experimental
Arm Description
Participants will receive problem-solving therapy integrated with adherence-enhanced procedures (PSA).
Arm Title
PID-C
Arm Type
Active Comparator
Arm Description
Participants will receive adherence-enhanced (PID-C) procedures, a treatment mobilizing patients to participate in their care.
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving-Rx Adherence (PSA)
Intervention Description
In PSA, a therapist teaches the participant to identify problems related to depression, functioning, and treatment adherence; to generate multiple solutions; and to choose and implement one or more of those solutions.
Intervention Type
Behavioral
Intervention Name(s)
PID-C
Intervention Description
In PID-C, a therapist identifies obstacles to treatment adherence and helps the participant overcome those obstacles.
Primary Outcome Measure Information:
Title
Depressive symptoms
Time Frame
Measured at week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets American Thoracic Society criteria for COPD Meets DSM-IV criteria for unipolar major depression Scores greater than 19 on 24-item Hamilton Depression Rating Scale Fluency in English sufficient for comprehending the questionnaires of the study and for understanding the therapists Exclusion Criteria: Unable to give informed consent Experiencing suicidal thoughts History of or currently meets DSM-IV criteria for the following Axis I disorders: psychotic depression, psychotic disorder, bipolar disorder, dysthymic disorder, obsessive compulsive disorder, or current substance abuse Meets DSM-IV criteria for Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV) Scores less than 24 on Mini-Mental State Exam (MMSE) or meets DSM-IV criteria for dementia Certain illnesses (e.g., untreated thyroid or adrenal disease, pancreatic cancer, lymphoma) Taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids) Current involvement in psychotherapy Requires nursing home placement after discharge
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George S. Alexopoulos, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
Weill Medical College of Cornell University
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Problem-Solving Therapy for People With Major Depression and Chronic Obstructive Pulmonary Disease

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